Contraceptive Pill and Hormonal Vaginal Ring in Women With Polycystic Ovary Syndrome

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The main aims of this study are:

• to investigate and compare the effects of long lasting use (59 weeks) of vaginal and oral contraceptives on androgen secretion, insulin and glucose metabolism, lipid profile, and serum levels of SHBG and hs-CRP in women with PCOS.

• to compare the metabolic effects of oral and vaginal combined contraceptives and to find out whether oral or transvaginal contraceptive can be recommended to a particular group of women, for example in women with increased metabolic risks.

• to clarify whether the unfavourable effects of combined contraceptives diminish with time (after use of one year).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Oulu
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Desogestrel; NuvaRing

Criteria

Inclusion Criteria:

• women aged between 18 to 40 years

• diagnosed PCOS (Rotterdam criteria)

• healthy, no medications

• no use of hormonal contraceptives or wash-out period of at least two months

• no contraindications to hormonal contraception

Exclusion Criteria:

• regular smoking

• excessive alcohol use

• pregnancy or breastfeeding

• oversensitivity to active ingredients

• migraine with focal aura

• severe or multiple risk factors to thrombosis

• diagnosed or suspected cancer

• diagnosed or suspected estrogen-dependent tumor

• acute or chronic hepatocellular disease -related abnormal liver function

• hepatic adenomas or carcinomas

• undiagnosed abnormal vaginal bleeding